Abstract In this Phase II SBIR project ASTER Labs will enhance a wireless WiFi-based insole that was designed and successfully tested and evaluated during a Phase I trial with elderly persons with dementia and their caregivers, and then investigate its efficacy in reducing caregiver activity and burden, and improving caregiver quality of life. An estimated 5.4 million Americans had Alzheimer's disease in 2016 and a 50% increase in this number is expected by 2030. The majority of these patients (70%) will live at home where they receive 75% of their care from informal, unpaid caregivers, such as family members, friends, and neighbors. These caregivers provide valuable services, often at great economic and psychological cost to themselves. In 2015, over 18 billion hours of unpaid care were estimated to have been provided by over 15 million caregivers. Around 15% of them quit their job or reduced their hours to provide this care. This translated to nearly $222 billion dollars of unpaid care in a single year. In the absence of a cure, dementia patients and caregivers prioritize quality of life as their most valued outcome. Existing commercial solutions to assist caregivers in locating wandering patients lack reliable functionality for indoor environments, require significant infrastructure enhancement, or burden both patient and caregiver with the use of non-discreet electronics packages that must be worn as wristbands or belt mounts. There exists an unmet need to support caregivers by providing a comprehensive localization solution of the patient that works both indoors and outdoors with little to no infrastructure modifications. ASTER Labs' novel device, referred to as Activlink, is a patient localization solution based upon WiFi signal and inertial sensors optimized to assist monitoring by primary and secondary caregivers of dementia patients in building environments. Activlink's purpose is to increase quality of life for caregivers by providing highly accurate indication of a patient's position, combined with real-time alerts of a patient's wandering movements. Caregiver often report reduced abilities to function in normal daily activities due to perpetual safety concerns and the demands of constantly monitoring their patient. Activlink provides on-demand access to real-time location visualization within a building, both while in relatively close proximity to the patient and remotely, for distant family members or secondary caregivers wishing to monitor the patient's location. The innovative concept design for this system provides continuous localization capabilities, so that the quality of life for both patient and caregiver may be enhanced by allowing both to move throughout a home or in large indoor spaces such as a care facility or medical center. This Phase II SBIR will evaluate the efficacy of the WiFi-based Activlink insole to provide caregivers with augmented patient awareness, aiming to immediately improve their quality of life by reducing their direct burden of continuous in care person oversight. Embedded randomized controlled evaluations will be completed using semi-structured interviews and observation data collected on 176 persons with moderate dementia, their family caregivers, and professional care providers.